Infectious Diseases Clinical Trial
Official title:
Determination of Estimated Sensitivity for Dengue NS1 ELISAs
This study is a multi-site trial assessing the sensitivity of DENV Detect™ NS1 ELISA versus
standard reference tests (e.g. PCR or viral culture) for dengue diagnosis in the US and
internationally.
The DENV Detect™ NS1 ELISA serves as an aid in the clinical laboratory diagnosis of early
stages of Dengue infection in patients with clinical symptoms consistent with Dengue
infection. This test is intended to be used on sera obtained within the first 7 days of
symptoms. DENV Detect™ NS1 ELISA results (positive or negative) must be confirmed by testing
with a reference standard test.
Subjects will be patients who present with symptoms consistent with dengue infection, such as
fever and myalgia. After informed consent is obtained and the subject is screened for
eligibility, 2 diagnostic samples will be collected. The first will be collected within the
first 7 days of symptoms onset, and the second will be collected at least 7 days later,
between the 10th and 21st days post-onset of symptoms.
ELISA and reference tests will be performed by different operators who are laboratory staff
members. These staff members, blinded to each other's results, will evaluate the samples from
each method independently.
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